NuCryo Vascular inks PolarCath distro deal with Lokai Medical

Privately held cryoplasty developer NuCryo Vascular said today it inked a deal with Lokai Medical to distribute its PolarCath balloon dilation system in the US.

San Jose, Calif.-based NuCryo Vascular’s PolarCath system is designed to be used in Balloon Cryoplasty procedures to treat peripheral artery disease. The system has FDA approval and is cleared to dilate stenosis in the peripheral vasculature and for treating obstructive lesions of polytetrafluorethylene access grafts or arteriovenous dialysis fistulae, the company said

The PolarCath, which won clearance initially in 2002, was purchased along with the company CryoVascular by Boston Scientific (NYSE:BSX) in 2005. Boston Scientific discontinued manufacturing of the PolarCath at the end of 2012, and NuCryo Vascular was formed to re-acquire and re-launch the device. NuCryo Vascular said it has re-engineered the device and won FDA approval for the non-sterile inflation device in 2015.

“We are very excited to partner with Lokai Medical and the company’s experienced sales team to help commercialize the PolarCath balloon dilatation system. NuCryo grew sales by 36 percent in 2017 vs. 2016 with an extremely small but dedicated direct sales team. The commercialization support and clinical expertise of Lokai Medical will help NuCryo continue its double-digit growth in the expanded markets we can now serve,” NuCryo Vascular exec VP & GM Kevin Beedon said in prepared remarks.

“I am very excited for the next-generation reusable Cryoplasty inflation device that NuCryo has re-engineered and brought back to market. As a previous Cryoplasty user with Boston Scientific, I recently reincorporated it back into my peripheral treatment algorithm and have been extremely happy with the results. In addition, the cost, ease of use, and time savings as compared to other balloons on the market have been well received at my facility,” interventional cardiologist Dr. Jonathan Aliota said in a press release.